MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT EG7+ CARTRIDGE

Catalog Number 03P76-25

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Sepsis (2067); Septic Shock (2068); Diabetic Ketoacidosis (2364); Respiratory Acidosis (2482)

Event Date 12/17/2022

Event Type  malfunction  

Event Description

On 20-dec-2022, abbott point of care was contacted by a customer regarding i-stat eg7+ cartridges that yielded a suspected discrepant hemoglobin results on a patient with diabetic ketoacidosis and cholangitis.There was no additional patient information available at the time of this report.Patient's clinical symptoms were septic shock, acidosis, unconscious, unstable vital sign.Customer states that the patient died that night.(b)(6).At this time there is no reason to suspect a malfunction exists.The patient died as a result of complications related to septic shock, acidosis, unconscious, unstable vital sign as presented.There is no reason to suspect that the i-stat caused or contributed to the patient's demise.The reporting decision was based on information available that suggests the product was not performing within the variability of the assay.The investigation is underway.

Manufacturer Narrative

Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.

Manufacturer Narrative

Apoc incident: # (b)(4).The investigation was completed on 01-feb-2023.A review of the device history record (dhr) confirmed the cartridge lot met finished goods release criteria.Retained cartridge testing met the acceptance criteria found in q04.01.003 rev.Ak, appendix 1 - product complaint level 2 and level 3 investigation procedure.No deficiency has been determined for eg7+ cartridge lot n22194.

Event Description

Na.

• Brand Name: I-STAT EG7+ CARTRIDGE
• Type of Device: EG7+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• Manufacturer (Section G): ABBOTT POINT OF CARE CANADA LTD.; 185 corkstown road; ottawa, ontario K2H 8 V4; CA K2H 8V4
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 16042762
• MDR Text Key: 308348239
• Report Number: 2245578-2022-00168
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K940918
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2023
• Device Catalogue Number: 03P76-25
• Device Lot Number: N22194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1